SHELHIGH NO-REACT BIOCUFF— 510(k) K032893

Name: FDA 510(k) clearance K032893
Creator: U.S. Food and Drug Administration
Published: 2003-12-19

Substantially Equivalent

Shelhigh, Inc.

FDA 510(k) clearance K032893 for SHELHIGH NO-REACT BIOCUFF, Substantially Equivalent on 2003-12-19. Applicant: Shelhigh, Inc.. Device class: 2.

Clearance details

Applicant: Shelhigh, Inc.
Product code: Code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2003-09-17
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Shelhigh, Inc.

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K023940 — SHELHIGH BIORING2003-06-04
K982101 — SHELHIGH NO-REACT DURA SHIELD2000-05-02
K991567 — SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.1999-07-14
K982810 — SHELHIGH NO-REACT VASCUPATCH1998-10-28
K981756 — SHELHIGH NO-REACT PNEUMOPLEDGETS1998-08-05

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.